Bumetanide Tablets Recalled for Exposure to Improper Storage Temperatures
Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a manufacturing process deviation (temperature excursion) affecting a prescription medication. While no adverse events are reported in the source, temperature-induced pharmaceutical degradation poses a potential risk to patients dependent on this medication for managing serious heart and circulatory conditions.
Plain-English summary
Amneal Pharmaceuticals is recalling Bumetanide Tablets, USP, 2 mg in bottles of 100 tablets, distributed by Cardinal Healthcare. The recall affects batch AM211171, which was distributed nationwide.
The recall is prompted by a Current Good Manufacturing Practice (CGMP) deviation. Products in this batch were exposed to temperatures outside of the product's labeled storage conditions during manufacturing or distribution. Temperature excursions can compromise pharmaceutical stability and drug efficacy.
Bumetanide is a prescription loop diuretic used to treat heart failure, edema, and other conditions involving fluid overload. Patients who have received this batch from the recalled lot should consult with their healthcare provider or pharmacist.
The recalled product
- Product
- Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- temperature-excursion
- potential-degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch AM211171
Distribution
Distributed nationwide across the United States.
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